Latest COVID-19 Vaccine Candidate Seeks Emergency FDA Approval

There is a very real fear that the Thanksgiving holiday will turn out to be a super-spreader event that thrusts the coronavirus crisis into overdrive as we approach the thickest part of the holiday season.

Some of these fears manifested after the FAA and other travel authorities remarked on how many Americans were traveling for the Thanksgiving holiday – even after having been warned repeatedly and pointedly to avoid such activity.

You see, without a vaccine, there is little left for us to do in terms of mitigating the effects of the virus.  Social distancing has been difficult for the jaded and annoyed Americans, and mask-wearing has become a political hot-button issue.

Luckily, the latest vaccine announcement from Moderna seems to be on the fast track to saving us.

Moderna announced Monday it will ask the Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company, after Pfizer, to seek EUA for a COVID-19 vaccine in the United States.

Pfizer’s public FDA hearing — a crucial step in the authorization process — is scheduled for Dec. 10, and the FDA could make its official authorization decision shortly thereafter.

In an early morning press release, Moderna announced that its FDA hearing will be held a week later, on Dec. 17. Moderna also announced its coronavirus vaccine is more than 94% effective, according to the final analysis of its massive Phase 3 trial.

Among the more than 30,000 volunteers in Moderna’s Phase 3 trial, 196 ultimately developed COVID-19, but the vast majority of those COVID-19 cases happened among volunteers who had been given a placebo injection — an imbalance hefty enough for biostatisticians to feel confident the vaccine is highly effective.

Studies have shown, however, that a large portion of the American population remains reluctant about the idea of being mandated to take such a vaccine, which could create issues as we look to return to normalcy.